Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Medtronic Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E; Ms Mvs11; Mounds View, MN 55112
• PMA Number: P980016
• Supplement Number: S965
• Date Received: 08/26/2026
• Decision Date: 09/25/2026
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
updates to visual inspection criteria for anode components at the Medtronic Energy and Component Center (MECC)